ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01


Device Classification Name

enzyme immunoassay, diphenylhydantoin

510(k) Number K080696
Device Name ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
Applicant
ABBOTT LABORATORIES
100 abbott park rd.
abbott park, 
IL 
60064

Applicant Contact carol jochum
Correspondent
ABBOTT LABORATORIES
100 abbott park rd.
abbott park, 
IL 
60064

Correspodent Contact carol jochum
Regulation Number 862.3350
Classification Product Code
DIP  
Subsequent Product Code
LGR  
Date Received 03/12/2008
Decision Date 09/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No